In late 2010, California was one of several states scrambling for thiopental, an anesthetic and part of a three-drug cocktail for lethal injections, when the domestic pharmaceutical manufacturer ran out of supplies. The California Department of Corrections and Rehabilitation purchased the drug from Dream Pharma, a one-man wholesaler that operated out of the back of a London driving school. Prison officials in Tennessee, Arizona, South Carolina and Georgia did the same.
The Food and Drug Administration allowed the states to import the thiopental – including 521 grams of the drug for California – in January 2011, arguing that execution-drug regulation is not its job.
A group of prisoners on death row filed a lawsuit against the FDA to force the agency to include lethal injection drugs within its jurisdiction. U.S. District Judge Richard Leon agreed and in March ruled that the federal agency had to confiscate the thiopental purchased from Dream Pharma.
"Here, the threatened injury that unapproved foreign thiopental will fail to anesthetize plaintiffs properly during execution, causing conscious suffocation, pain, and cardiac arrest is, to say the least, severe," Leon wrote. "Indeed, few in our society are more vulnerable than a death row inmate facing lethal injection."
Leon called the thiopental from Dream Pharma "misbranded" and "unapproved" in his order.
At the urging of state prison officials, the FDA filed paperwork last week indicating that it intends to appeal Leon's ruling.
Federal law is written so that the FDA can prevent drug abuse and illicit distribution of controlled substances, Benjamin Rice, an attorney for the California corrections department, said in a letter to the agency on May 1. "These purposes would not be served or advanced by a strained interpretation making (drug-control laws) applicable to a state's execution statutes or protocols," Rice wrote.
Regardless, the agency still aims to follow the court order and confiscate California's thiopental, said Domenic Veneziano, director of import operations and policy at the FDA.
Sodium thiopental is a common anesthetic, useful for rendering patients unconscious during general surgery and deemed a core medicine by the World Health Organization.
The California corrections department had its supply tested independently, finding the drug meets quality standards. The lab report states that pharmacological potency of tested doses was 93.7 percent, with acceptably low levels of heavy metals and impurities.
The sodium thiopental expires in March 2014, according to the drug's label.
The state may never get to use the thiopental.
Another federal court order halted executions in California six years ago over problems with its execution facility and protocols. In November, the state's voters will decide whether to end the death penalty all together. A ballot measure – called the The Savings, Accountability and Full Enforcement for California Act – would convert death sentences for more than 700 prisoners to life terms and remove execution as a penalty going forward.
Story courtesy of our media partners at California Watch (A Project of the Center for Investigative Reporting)